For medical devices, the most important goal of the human factors/usability engineering process is to minimize use-related hazards and risk then validate that users can use the device safety and effectively.
For products marketed in the United States, the FDA is the regulatory body. For products marketed in other regions such as the European Union, local regulatory authorities provide oversight.
If you need a regulatory team, we can provide that service.
Folow the links below for regulatory, ISO, and CE marking resources.
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21 CFR Parts: 11, 50, 54, 56, 312, 314; 810, 820
ICH E6, E8, E9, E10, Q7, Q8, Q9, Q10
ISO 13485:2003 Quality Management System for Medical Devices
ISO: 14155:2011 Clinical investigation of Medical Devices for Human Subjects
ISO 14971:2012 Medical Device Application of Risk Management to Medical Devices
ISO 10933 Biological evaluation of devices